Quantitative ICG Fluorescence Angiography in Colorectal Surgery (QUANTICO)

Zealand University Hospital

Status: Completed

Conditions: Anastomotic Leak; Colorectal Cancer

Treatments: Other: Quantitative Indocyanine Green Fluorescence Angiography

Study type: Observational

Funder types: Other

Identifiers

NCT05153954

REG-046-2021

Details and patient eligibility

About

Fluorescence angiography with indocyanine green (ICG-FA) has gained increased popularity in colorectal surgery to check perfusion to the newly-formed anastomotic area and decrease the rate of postoperative anastomotic leakage.

While qualitative ICG assessment has the advantage to be used instantly during the operative procedure, it does bear drawbacks (subjective assessment, dependent on factors like camera distance, ICG dose and white-light contamination).

The alternative is quantitative ICG assessment, which is performed by evaluating the time-intensity curve of the ICG-FA with an external analyzing software. The procedure is showing promising results, but the methodology is still reported very heterogeneously.

This study is a multi-center, prospective, standardized, surgeon-blinded observational trial. The key aspect of this study is the non-interventional design with blinding of both the qualitative and quantitative results from the ICG perfusion measurement, providing no chance of influencing the course of the operation. Assessment of perfusion will be performed postoperatively blinded to the outcome. Assessment of the pre-anastomotic area is intraoperatively performed by an image analysis software that then calculates a perfusion score based on an algorithm integrating relevant perfusion metrics. The primary outcome is the combined rate of early and late anastomotic complications within 90 days postoperatively.

Enrollment: 114 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 18 years or older
• Capable of giving informed consent
• ASA Classification: status I-III
• Planned for PME or TME with minimally invasive approach and primary anastomosis
• Strong suspicion of or biopsy-verified sigmoid or rectal cancer Stage I-IV cancer

Exclusion criteria

• Known allergy to ICG or iodine
• Emergency procedure
• Pregnancy or if the patient is currently nursing
• Surgeons decide to do unblinded quantitative or qualitative ICG-FA

Trial design

114 participants in 1 patient group

Colorectal cancer patients

Description:

Patients who can be treated with either PME or TME and receive a primary anastomosis during surgery.

Treatment:

Other: Quantitative Indocyanine Green Fluorescence Angiography